Experteer Overview
In this role you support GMP-aligned manufacturing, packaging, and product quality within a global allergy-focused pharma company. You drive continuous improvement of QA principles, ensure robust quality systems, and help maintain inspection readiness. You will collaborate with cross-functional teams to resolve GMP issues and uphold high regulatory standards. This is an opportunity to influence quality across multiple sites and contribute to safer, compliant products for patients.

Compensaciones / Beneficios
• Perform QA activities for internal Quality Systems (technical complaints, change controls, CAPAs, deviations)
• Lead and coordinate APQR inputs and APQR subsystem in the general forum
• Review GMP technical and validation reports across manufacturing, packaging, and systems
• Validate cleaning, equipment qualification, and analytical methods
• Provide on-site guidance for procedures and working instructions
• Support Documentation and Training: reinforce good documentation practices and GMP-training
• Support Quality Release: master batch records review and site master file updates




• Help resolve GMP issues by identifying problems, refining systems, and coaching personnel
• Maintain inspection readiness and provide GMP quality expertise as required

Responsabilidades
• Minimum of 3 years' experience in pharmaceutical/biotech
• Studies related to Chemistry, Pharmacy, Biology or equivalent (university studies valued)
• Fluent in English (written and spoken)
• Knowledge of regulations for sterile medicinal products and experience with technology transfer (equipment qualification and process validation)
• Previous experience as a Qualified Person and SAP proficiency desirable
• Strong interpersonal and leadership skills across cultures, with ability to handle ambiguity
• Flexibility and strong learning aptitude to support QA functions

Requisitos principales
• Attractive salary
• comprehensive benefits
• work-life balance
• tailored training opportunities
• international exposure
• career growth

📌 QA Specialist (Madrid)
🏢 Alk Abello
📍 Madrid